Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Atorvastatin Group | A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days. Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml). | None | None | 0 | 19 | 0 | 19 | View |
| Placebo Group | A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days. Non medicated dentifrice: fluoride dentifrice. | None | None | 0 | 19 | 0 | 19 | View |